First-entry trocar system

ABSTRACT

A surgical access system comprises a trocar, an insufflating optical obturator slidably insertable into the trocar, and a laparoscope slidably insertable into the obturator. A distal end of the obturator comprises a tip, at least a portion of which comprises a wall with a generally uniform thickness comprising a transparent material. At least one vent hole disposed at the obturator tip is fluidly connected to a gas flow channel defined by an interior surface of the obturator and the laparoscope, which is fluidly connected to an insufflation gas inlet disposed at a proximal end of the trocar. Improved optical characteristics of the trocar system permit precise and accurate visual placement thereof into a body cavity. Accordingly the access system is suitable as a first entry surgical access system. Embodiments of the trocar access are also useful for drug delivery, and/or for fluid and/or tissue aspiration.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.12/569,652 filed on Sep. 29, 2009 entitled “Trocar system withlaparoscope and gas channel” which claims priority to and benefit ofU.S. Provisional Patent Application No. 61/101,061 filed on Sep. 29,2008 entitled “First entry trocar system”; the entire disclosures of allof these applications are incorporated by reference in their entiretiesherein.

BACKGROUND

1. Technical Field

This disclosure is generally directed to surgical access devices, andmore particularly, to a first-entry surgical access system.

2. Description of the Related Art

Trocars are used for instrument access to body cavities in minimallyinvasive surgery, for example, laparoscopic surgery. In laparoscopicsurgery of the organs of the abdomen, the abdomen is typically inflatedor insufflated with an insufflation gas, for example, carbon dioxide,which lifts the abdominal wall away from the internal organs, therebyfacilitating access to the organs, a condition referred to aspneumoperitoneum. Inserting trocars into an abdomen underpneumoperitoneum is relatively easy. Because the abdominal wall isdistended away from the internal organs by the pressure of theinsufflation gas, inadvertent damage to the organs during insertion isreduced. Before pneumoperitoneum is established, however, the abdominalwall through which the trocar is to be inserted contacts the internalorgans directly. Consequently, inserting the first trocar, referred toas first entry, carries an increased risk of damaging the internalorgans directly beneath the entry point.

SUMMARY OF THE INVENTION

A surgical access system comprises a trocar, an insufflating opticalobturator slidably insertable into the trocar, and a laparoscopeslidably insertable into the obturator. A distal end of the obturatorcomprises a tip, at least a portion of which comprises a wall with agenerally uniform thickness comprising a transparent material. At leastone vent hole disposed at the obturator tip is fluidly connected to agas flow channel defined by an interior surface of the obturator and thelaparoscope, which is fluidly connected to an insufflation gas inletdisposed at a proximal end of the trocar Improved opticalcharacteristics of the trocar system permit precise and accurate visualplacement thereof into a body cavity. Accordingly the access system issuitable as a first entry surgical access system. Embodiments of thetrocar access are also useful for drug delivery, and/or for fluid and/ortissue aspiration.

Some embodiments provide a bladeless trocar that permits visualizationof body tissue fibers as they are being separated, thereby permitting acontrolled traversal across a body wall. Some embodiments provide abladeless trocar that accommodates a conventional laparoscope. Someembodiments provide a trocar that enables insufflation of a body cavityand contemporaneous visualization thereof through the distal tip of theobturator.

Some embodiments provide a surgical access system comprising: a tubulartrocar comprising a longitudinal axis, a proximal end, a distal end, anelongate cannula, and a seal assembly disposed at a proximal end of thecannula; an insufflating obturator slidably insertable into the trocar,the obturator comprising a longitudinal axis, a proximal end, a distalend, a tubular shaft, a tip disposed at the distal end of the shaft, atleast one vent hole disposed on the tip, and a handle disposed at theproximal end of the shaft; and a fluid inlet disposed at a proximal endof the access system. At least a portion of the obturator tip comprisesa wall comprises a transparent material with a substantially uniformthickness, the obturator slidably receives a laparoscope into theobturator shaft, and an interior surface of the obturator shaft and tip,and an outer surface of an inserted laparoscope together define ainsufflation gas flow channel fluidly connecting the at least one venthole to the fluid inlet.

In some embodiments, the seal assembly comprises a septum seal and aduckbill valve.

In some embodiments, the fluid inlet is disposed on the proximal end ofthe trocar.

In some embodiments, the obturator tip is bladeless. In someembodiments, the wall of the obturator tip is not greater than about0.65 mm thick. In some embodiments, the obturator tip has asubstantially uniform wall thickness. In some embodiments, the obturatorshaft and tip are unitary. In some embodiments, the obturator tipcomprises at least one of polymer, polycarbonate, polysulfone, PEEK,polyether block amide (PEBAX®), polyester, copolyester, and acrylic.

In some embodiments, the obturator tip comprises a single vent hole. Insome embodiments, the at least one vent hole is at least one ofcircular, oval, elliptical, tear-drop shaped, slot shaped, slit shaped,chevron shaped, triangular, rectangular, rhomboid, and polygonal.

Some embodiments further comprise a depth indicator on the obturatortip. In some embodiments, the depth indicator comprises at least one ofindicia disposed in a bore of the at least one vent hole, and indiciadisposed proximate to the at least one vent hole.

In some embodiments, the obturator further comprises at least onelaparoscope stop disposed on at least one of the interior surface of theobturator tip and the interior surface of the obturator shaft. In someembodiments, the interior surface of the obturator tip comprises anon-circular transverse cross section.

In some embodiments, the obturator accommodates laparoscopes withvarying diameters. In some embodiments, the obturator tip accommodates adistal end of the laparoscope.

In some embodiments, at least one opening perforates the obturatorshaft.

In some embodiments, a cross-sectional area of the insufflation gas flowchannel is at least about 1.6 mm². In some embodiments, a flow ratethrough the access system is at least about 3.5 L/min at an insufflatorsetting of about 1.6-2 KPa.

Some embodiments further comprise a laparoscope.

Some embodiments further comprise at least one of a gas flow indicator,an audible gas flow indicator, and a visual gas flow indicator.

Some embodiments provide a method for accessing a targeted body region,the method comprising: inserting a laparoscope into the surgical accesssystem, wherein the obturator is inserted into the trocar; contactingthe obturator tip with a body wall; advancing access system through thebody wall; observing a position of the obturator tip through thelaparoscope; and terminating advancement of the trocar system when theobturator tip is observed to reach a targeted body region.

In some embodiments, the targeted body region is a body cavity.

In some embodiments, observing the position of the obturator tipcomprises observing the position of the at least one vent hole.

Some embodiments further comprise coupling the gas inlet of the surgicalaccess system to a source of insufflation gas. Some embodiments furthercomprise at least one of delivering a medicament through the at leastone vent hole to the targeted body region; delivering a fluid;aspirating a fluid; and withdrawing tissue.

Some embodiments further comprise removing the obturator from thetrocar.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a front view and FIG. 1B is a side view of an embodiment of asurgical access system comprising a trocar, an insufflating opticalobturator, and a laparoscope. FIG. 1C is a front cross-sectional viewand FIG. 1D is a side cross-sectional view a distal end of theinsufflating optical obturator illustrated in FIGS. 1A and 1B with alaparoscope inserted therein. FIG. 1E is a top view of a transversecross section of a tip of the insufflating optical obturator illustratedin FIGS. 1A-1D.

FIG. 2A is a side cross-sectional view and FIG. 2B is a frontcross-sectional view of a distal end of another embodiment of aninsufflating optical obturator with a laparoscope inserted therein. FIG.2C is a top view of a transverse cross-section of a tip of theinsufflating optical obturator and laparoscope illustrated in FIGS. 2Aand 2B.

FIG. 3A is a longitudinal cross-section of another embodiment of aninsufflating optical obturator. FIG. 3B is a detailed cross section of ahandle of the insufflating optical obturator illustrated in FIG. 3A.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

FIGS. 1A and 1B are front and side views of an embodiment of a surgicalaccess or trocar system 1000, which is suitable, for example, as a firstentry trocar system. The illustrated embodiment is suitable, forexample, as a 5-mm trocar system, as well as for trocar systems of othersizes. The illustrated access system 1000 comprises a trocar 1100, anobturator 1200, and a laparoscope 1300.

The trocar 1100 comprises a longitudinal axis, a proximal end, and adistal end. The proximal end is disposed proximal to a user, forexample, a surgeon, during use. Conversely, the distal end is disposedaway from the user during use. The obturator 1100 comprises a tubularcannula 1110 and a trocar seal assembly 1120 disposed at the proximalend of the cannula 1110. In the illustrated embodiment, the sealassembly 1120 comprises a fluid inlet comprising a Luer fitting 1122 anda stopcock 1124. In other embodiments, the fluid inlet has a differentconfiguration and/or is disposed on another component, for example, onthe obturator 1100.

In the illustrated embodiment, the obturator 1200 is an insufflatingoptical obturator, as will be described in greater detail below. Theobturator 1200 comprises a longitudinal axis, a proximal end, and adistal end. The obturator 1200 comprises an elongate shaft 1210, whichis dimensioned for slidable insertion into and removal from the tubularcannula 1110 of the trocar, a tip 1220 disposed at the distal end of theshaft 1210, and a handle 1230 disposed at the proximal end of the shaft1210. In some embodiments, the obturator tip 1220 is a bladeless tip. Inother embodiments, the tip 1220 has another configuration useful fortraversing and/or penetrating body tissue, for example, a sharp tip, apointed tip, a pyramidal tip, a bladed tip, a conical tip, and/or a tipcomprising one or more sharp edges or sharpened edges. In otherembodiments, the tip 1220 is a radiused blunt tip, which is advantageousfor traversing an existing body orifice, and/or relatively soft or fattytissue.

The trocar 1100 and obturator 1200 independently comprise any suitablematerial. Those skilled in the art will understand that differentcomponents of the trocar 1100 and/or obturator 1200 comprise differentmaterials in some embodiments. Suitable materials include, for example,at least one of a polymer, metal, ceramic, and the like. Suitablepolymers include engineering polymers, polycarbonate, polysulfone, PEEK,polyether block amide (PEBAX®), polyester, copolyester, acrylic, and thelike. Some embodiments of the trocar 1100 and/or obturator 1100 furthercomprise a composite, for example, a fiber-reinforced polymer. In someembodiments, a stronger material permits reducing a wall thickness of acomponent without reducing the strength thereof. For example, someembodiments of a metal or composite obturator shaft 1210 are thinnerthan a corresponding polymer version, thereby increasing the diameter ofa lumen thereof without increasing the outer diameter. As discussed indetail below, increasing lumen diameter improves gas flow through thedevice.

For example, in some embodiments, obturator shaft 1210 comprises a metaltube, for example, a stainless steel tube, with a polycarbonate tip 1220insert molded onto the tube. In some embodiments, the metal tube has awall thickness as thin as about 0.003″ (about 0.076 mm). An metalobturator shaft 1210 with an inside diameter of about 0.235″ (about 6mm) and an outside diameter of about 0.241″ (about 6 mm) provides anacceptable insufflation gas flow rate. The relationship between gas flowrate and component dimensions and configurations is discussed in detailbelow.

Embodiments of the cannula 1110 typically comprise a rigid material.Some embodiments of the obturator shaft 1210 comprise a rigid materialand/or a flexible material because the obturator shaft 1210 is largelysupported by the cannula 1110 during use in some embodiments.

The laparoscope 1300 comprises a proximal end and a distal end 1304(FIGS. 1C and 1D). The laparoscope 1300 is of any suitable type, forexample, comprising an eyepiece at a proximal end and an objective at adistal end thereof. The distal end 1304 of the laparoscope 1300 isdimensioned for slidable insertion into and removal from the obturatorshaft 1210.

FIG. 1C is a front cross-sectional view and FIG. 1D is a sidecross-sectional view of the distal end of the insufflating obturator1200 with a laparoscope 1300 inserted therein. The illustratedembodiment depicts a bladeless obturator 1200 suitable for visualizationand insufflation therewith. The device include a pair of vent holes 1222at the distal tip 1220 of the bladeless obturator, through which aninsufflating gas, such as carbon dioxide, flows into a body cavity, asdiscussed in greater detail below. Other embodiments comprise more orfewer vent holes 1222. For example, some embodiments of the tip 1220 ofthe obturator comprise a single vent hole 1222. In the illustratedembodiment, the vent holes 1222 are generally circular. In otherembodiments, the vent holes 1222 have another shape, for example, oval,elliptical, tear-drop shaped, slot shaped, slit shaped, chevron-shaped,triangular, rectangular, rhomboid, polygonal, and the like. In someembodiments, at least one vent hole 1222 has a different shape fromanother vent hole 1222.

In some embodiments, the obturator 1200 is an optical obturator in whichat least a portion of a distal end of the tip 1220 of the bladelessobturator comprises a generally transparent or translucent material,through which tissue is visualized during the insertion of the obturator1200 through a body wall. Embodiments of the bladeless obturator 1200are dimensioned and configured to receive therein any suitablelaparoscope 1300, which typically includes an imaging element and fiberoptic light fibers (not illustrated). The illustrated embodiment of thetip 1220 comprises at least one laparoscope stop 1224, which assists inpositioning the laparoscope 1300 within the obturator 1200. In otherembodiments one or more laparoscope stops are disposed within theobturator shaft 1210 and/or at the intersection of the shaft 1210 andtip 1220. Other embodiments do not comprise a laparoscope stop.

The illustrated embodiment of the bladeless optical insufflatingobturator 1200 includes a tip 1220 configuration comprising one or morefeatures that enhance the visualization and clarity through the tip ofthe obturator. The illustrated transparent tip 1220 of the obturatorthrough which tissue is observed comprises a wall 1225, at least aportion of which has a substantially uniform thickness. The uniform wallthickness reduces distortion of an image observed through the obturatortip 1220. In some embodiments, the entire obturator tip 1220 comprises asubstantially uniform wall thickness. Embodiments of bladeless opticalobturators comprising non-uniform wall thicknesses typically exhibitless clear imaging through the obturator tip because the varying wallthickness distorts the image transmitted therethrough, for example, inbladeless optical obturators comprising a generally circular innercontour and a generally rectangular outer contour.

FIG. 1E is a top view of a transverse cross section of the obturator tip1220 illustrated in FIGS. 1A-1D. In the illustrated embodiment, an innercontour 1226 of the obturator tip 1220 has a generally rectangulartransverse cross section, which substantially matches an outer contour1228 of the obturator tip, which also has a generally rectangulartransverse cross section. In other embodiments, the inner and outertransverse cross-sectional contours 1226 and 1228 of the obturator tip1220 have another shape, for example, generally elliptical, hexagonal,S-shaped, or another suitable shape. In some embodiments, a portion ofan interior surface the tip 1220 at which the distal end laparoscope1300 contacts has a contour different from a shape or contour of thedistal end of the laparoscope. For example, in embodiments in which thedistal end of the laparoscope 1300 is circular, the portion of the tip1220 at which the distal end of the laparoscope 1300 contacts is notcircular, thereby defining a gas flow channel therebetween, as discussedin greater detail below.

In some embodiments, at least a portion of the wall 1225 of theobturator tip 1220 comprises a thin-wall configuration. The thin-wallconfiguration enables light to travel through the material with reducedloss in intensity, thereby enhancing the visibility of tissue throughthe obturator tip 1220 as the obturator is advanced and placed into thetargeted body cavity. The thin-wall configuration also reducesdistortion of the image viewed through the obturator tip 1220 andmaintains the color accuracy of the viewed tissue. Some embodiments ofthe obturators 1200 have tip wall thicknesses of from about 0.02″ (about0.5 mm) to about 0.025″ (about 0.65 mm) for about 5-mm to 12-mmobturators. In some embodiments, the tip wall is thicker, for example,to provide additional strength.

All transparent materials have a light transmittance value of less than100%. That is, less than 100% of the light incident on the material istransmitted directly through the material. For a given transparentmaterial, as the wall thickness of the material increases, the amount oflight that travels through the material decreases. Moreover, because theilluminating light is directed from within the obturator 1200, the lightmust travel through the obturator tip 1220 twice, thereby doubling theloss of light due to the transmittance characteristics or absorption ofthe obturator tip 1220. Embodiments of an obturator tip 1220 with areduced wall thickness reduce the loss of light or absorption thereby,thereby improving the image of the tissue through which the obturator1200 is advanced, and maintaining the color accuracy and fidelity of theobserved tissue.

In some embodiments, the obturator shaft 1210 and tip 1220 are injectionmolded as a unitary or single, integral component, which, in combinationwith the thin-wall tip 1220, allows positioning or placing a distal end1304 of the laparoscope (FIGS. 1C and 1D) in close proximity to and/orwithin the tip 1220 of the obturator. By placing the distal end 1304 ofthe laparoscope in close proximity to and/or within the tip 1220 of theobturator, an image produced through the laparoscope 1300 is magnifiedcompared with an image produced by a distal end 1304 of the laparoscope1300 positioned at a greater distance from the obturator tip 1220. Forexample, in some embodiments of a 5-mm bladeless optical obturatordesigned to accommodate laparoscopes with diameters of from about 5 mmto about 5.5 mm, the distal end of the laparoscope is positionable asclose as about 0.442″ (about 11 mm) from the distal end of the obturator1200. Some embodiments of a 12-mm bladeless optical obturator designedto accommodate about 10-mm diameter laparoscopes, permit positioning thedistal end of the laparoscope as close as about 0.79″ (about 20 mm) fromthe distal end of the obturator 1200 or less than about 0.83″ (about 21mm) from the distal end of the obturator 1200. In these embodiments, themagnification through the 5-mm optical obturator is greater than thatfor the 12-mm optical obturator.

The enhanced visibility through the tip 1220 of the obturator alsoenhances the visibility of the vent holes 1222 in the tip of theobturator. Consequently, in some embodiments, the vent holes 1222 areuseful as markers for indicating the penetration depth of the obturatortip 1220. As the surgeon advances the trocar system 1000 through tissue,the surgeon can view the vent holes 1222 through the laparoscope 1300,thereby observing when the vent holes 1222 have traversed a body wall,such as the abdominal wall. Once the vent holes 1222 have traversed abody wall and entered a body cavity, the trocar system 1000 need not beadvanced further. Accordingly, the enhanced visibility of the obturatortip 1220 permits precise placement of the access system 1000, andconsequently, the trocar 1100 into a body cavity, thereby preventing thetrocar 1100 from being advanced too far into the body cavity. Becausethe surgeon is able to precisely place the trocar system 1000 across abody wall until just the portion of the obturator tip 1200 comprisingthe vent holes 1222 is positioned within the body cavity, the risk ofinjury to internal body structures is reduced.

In some embodiments, one or more indicia are provided on at least onevent hole 1222, thereby increasing the utility, visibility, and/orprominence of the vent holes 1222 as depth indicators. For example, insome embodiments, one or more contrasting and/or fluorescent colors areprinted in the vent hole 1222 bores.

In some embodiments, one or more marker bands or indicia are disposedproximate to or near at least one vent hole 1222, for example, byprinting one or more contrasting or fluorescent marker bands. Theenhanced visibility through the tip 1220 of the obturator permits usingthe marker bands for monitoring the penetration depth of the obturator1200. For example, in some embodiments, the marker band is highlyvisible through the laparoscope 1300 as a rectangular band positionedjust proximal to the vent holes 1222. In other embodiments, the markerbands have another shape, for example, dots. As a surgeon advances theaccess system 1000 through the tissue, the surgeon can view the positionof the marker band to determine when the vent holes 1222 have traverseda body wall. The enhanced visualization through the obturator tip 1220enables precise placement of the trocar 1100 into a body cavity, therebypreventing the trocar 1100 from being advanced too far into the bodycavity. Precisely placing the access system 1000 across a body walluntil just the portion of the obturator tip 1220 with the vent holes1222 is in the body cavity reduces the risk of injury to internal bodystructures.

Referring to FIGS. 1C and 1D, some embodiments provide a devicecomprising an insufflation flow path or channel 1400 defined by an innerwall of the obturator shaft 1210 and the laparoscope 1300. For example,embodiments of a 5-mm bladeless optical trocar with a 5-mm obturator aredimensioned and configured to accommodate laparoscopes with diameters offrom about 5 mm to about 5.5 mm (from about 0.197″ to about 0.217″) withan insufflation flow channel 1400 extending longitudinally through theinside of the obturator between the outside wall of the laparoscope 1300and the inside wall of the obturator shaft 1210. The insufflation flowchannel 1400 is dimensioned to accommodate a suitable flow of aninsufflating gas, for example, carbon dioxide. In some embodiments, across-sectional area of the insufflation flow channel is at least about0.0025 in² (about 1.6 mm²) In the illustrated embodiment, an insidediameter of the obturator shaft 1210 is larger compared with the insidediameter of the obturator shaft of a typical 5-mm optical obturator.Increasing the inside diameter of the obturator shaft 1210 defines agenerally cylindrical flow channel 1400 sufficient for insufflation wheneither a 5-mm or 5.5-mm laparoscope 1300 is inserted into the obturator1200. In the illustrated embodiment, an outer diameter of the obturatorshaft 1210 is also increased. To accommodate the slightly largerobturator shaft 1210, in some embodiments, the inner diameter and outerdiameter of the trocar cannula 1110 are also increased compared withtypical a 5-mm trocar cannula.

EXAMPLE 1

A polycarbonate insufflating obturator was manufactured in which theinner diameter of the 5-mm insufflating obturator shaft was 0.235″ (6mm), the outer diameter was 0.272″ (6.9 mm), and the wall thickness was0.018″ (0.46 mm) The inner diameter of the mating 5-mm cannula was0.277″ (7 mm), the outer diameter was 0.343″ (8.7 mm), and the wallthickness of the cannula was 0.033″ (0.84 mm) Based on these dimensions,the cross-sectional area of the obturator flow channel with a 5.5 mmlaparoscope inserted therein was 0.0064 in² (4.1 mm²), which provides acarbon dioxide flow rate of about 6 L/min at an insufflator pressuresetting of about 1.6-2 KPa (about 12-15 Torr).

EXAMPLE 2 (COMPARATIVE EXAMPLE)

For comparison, a polycarbonate 5-mm bladeless optical trocar designedto accommodate 5-mm to 5.5-mm laparoscopes included an obturator with aninner diameter of 0.219″ (5.6 mm), an outer diameter of 0.225″ (5.7 mm),and a wall thickness of 0.003″ (0.076 mm) The mating cannula for thisobturator had an inner diameter of 0.227″ (5.8 mm), an outer diameter of0.287″ (7.3 mm), and a wall thickness of 0.03″ (0.76 mm) For comparison,the cross-sectional area of the obturator flow channel with a 5.5-mmlaparoscope inserted in the obturator was 0.00068 in² (0.44 mm²), whichprovides an insufficient flow of carbon dioxide through the device.

EXAMPLE 3

A 5-mm obturator is molded from polycarbonate with an inside diameter of0.230″ (5.8 mm) and a wall thickness of 0.021″ (0.53 mm). The carbondioxide flow rate through this obturator with a 5.5-mm laparoscopeinserted therein is about 3.5 L/minute at an insufflator pressuresetting of about 1.6-2 KPa (about 12-15 Torr). The increased wallthickness improves the injection molding process for manufacturing theobturator shaft.

The tip 1220 of a bladeless insufflating obturator is designed toseparate and dilate tissue and muscle fibers during traversal of a bodywall. Because of the dilating and separating properties of a 5-mminsufflating trocar, increasing the outer diameters of the obturatorshaft 1210 and the cannula 1110, as compared with typically sized 5-mmbladeless trocars, does not adversely affect the insertion force of thetrocar in the illustrated embodiment. The wall thickness of theobturator shaft 1210 is also sufficient to permit injection molding theshaft 1210 and tip 1220 as a single piece, thereby reducing the overalldevice cost and increasing production capacity.

FIG. 2A is a side cross-sectional view and FIG. 2B is a frontcross-sectional view of a distal end of another embodiment of aninsufflating optical obturator 2200 with a laparoscope 2300 insertedtherein. FIG. 2C is a top view of a transverse cross section of a tip2220 of the insufflating optical obturator 2200 and laparoscope 2300illustrated in FIGS. 2A and 2B. The following description refers to a12-mm obturator sized to accommodate 10-mm laparoscopes, which definesan insufflation flow channel sufficient for generating pneumoperitoneum.Those skilled in the art will understand that the illustrated embodimentis also scalable to other size trocar systems.

The illustrated 12-mm obturator also accommodates smaller laparoscopes2300 such as 5-mm and/or 5.5-mm diameter laparoscopes. The tip 2220 ofthe obturator is configured such that a distal end 2304 a 5-mm to 5.5-mmlaparoscope is insertable deep into a tapered portion of the obturatortip 2220, while still defining an insufflation flow channel 2400 with asufficient minimum area for a suitable flow of carbon dioxide around thelaparoscope 2300. In the illustrated embodiment, a shorter dimension orwidth of a generally rectangular internal surface 2226 of the tip of theobturator defines a stop for a 5-mm and/or 5.5-mm laparoscope 2300. Theinsufflation flow channel 2400 is defined by the area between theinternal longer dimension or internal length of the internal surface2226 of the tip and the outside wall of the laparoscope 2300, as bestviewed in FIGS. 2A and 2C. The insufflation flow channel 2400 is fluidlyconnected to one or more vent holes 2222 disposed on the tip. Theembodiment illustrated in FIG. 2A also comprises an optional stop 2224for a 10-mm laparoscope.

Some embodiments in which distal end of the 5-mm or 5.5 mm laparoscope2300 and the portion of the inner surface 2226 of the tip that acts as astop therefor have similar shapes do not provide an insufflation flowchannel 2400 with an sufficiently large minimum area to provide adesired insufflation gas flow. For example, inserting a roundlaparoscope 2300 into an obturator 2200 in which the stop portion of theinner surface 2226 has a circular transverse cross section provides onlya small or even no flow channel 2400, thereby effectively isolating thevent holes 2222 from the lumen of the shaft 2210 and preventing gas flowtherethrough.

The illustrated trocar system exhibits improved flexibility,versatility, and/or performance, while reducing cost and inventoryrequirements. Pairing a 5-mm and/or 5.5-mm laparoscope with a 12-mmobturator improves the flow rate of carbon dioxide through the obturator2200 with the laparoscope inserted therein compared with the flow ratethrough the obturator 2200 with a 10-mm laparoscope inserted therein.Also, a hospital or clinic may not have any 10-mm zero-degreelaparoscopes readily available, whereas many facilities have 5-mm and/or5.5-mm zero-degree laparoscopes readily available. Another advantage isthat the distal end of a 5-mm or 5.5-mm laparoscope is closer to thedistal end of the obturator tip 2200 compared with a 10-mm laparoscope,thereby providing a magnified image. For example, in the illustratedembodiment, the distal end of a 5-mm or 5.5-mm laparoscope is positionedat about 0.430″ (about 11 mm) from the distal end of the tip 2200 of theobturator, while the distal end of a 10-mm laparoscope is positioned atabout 0.790″ (about 20 mm) from the distal end of the tip 3220 of theobturator.

FIG. 3A is a longitudinal cross-section of another embodiment of aninsufflating obturator 3200 and FIG. 3B is a detailed longitudinal crosssection of a proximal end thereof. The insufflating obturator 3200comprises a shaft 3210, a tip 3220, and a handle 3230. The handle 3230comprises a funneled entry 3232 disposed at a proximal end thereof. Aseal assembly 3240 is disposed distally thereof. Accordingly, the sealassembly 3240 is spaced from and/or recessed from the proximal end ofthe obturator 3200, thereby encasing the seal assembly 3240 within thehandle 3230. Thus, in the illustrated embodiment, the seal assembly 3240is protected from direct user contact and/or manipulation. In someembodiments in which a seal assembly 3240 is disposed at the proximalend of the obturator 3200 and externally accessible, one or morecomponents of the seal assembly 3240 are vulnerable to inadvertentdeformation, for example, during placement of the trocar system, whichcan cause loss of pneumoperitoneum. Furthermore, in some embodiments,the seal assembly 3240 is vulnerable to deliberate and/or inadvertentremoval and/or loss. The illustrated seal assembly 3240 seals withinstruments of varying diameters as well as providing a zero seal in theabsence of an instrument. Again, using a 12-mm obturator as anillustrative example, the seal assembly 3240 seals with any of 5-mmlaparoscopes, 5.5-mm laparoscopes, and/or 10-mm laparoscopes, therebypreventing leakage of carbon dioxide from the proximal end of theobturator 3200.

In the illustrated embodiment of the obturator 3200, at least oneopening 3206 perforates the shaft 3210, fluidly connecting the interioror lumen with the exterior thereof. When inserted into a suitabletrocar, for example, embodiments of the trocar 1110 illustrated in FIGS.1A and 1B, the at least one opening 3206 fluidly connects the interioror lumen of the obturator 3200 to the fluid inlet 1122, therebypermitting fluid flow from the fluid inlet 1122, through the openings3210, and out the vent holes 3222. Some embodiments of the obturator3200 comprise a single opening perforating the shaft. In someembodiments, the opening or openings 3206 independently have anothershape, for example, circular, oval, elliptical, tear-drop shaped, slotshaped, slit shaped, chevron-shaped, triangular, rectangular, rhomboid,polygonal, and the like.

Referring to FIG. 3B, which is a detailed longitudinal cross section ofthe proximal end of the obturator 3200 illustrated in FIG. 3A, theillustrated seal assembly 3240 comprises an internal septum seal 3242and an internal duckbill valve 3244 disposed at the proximal end of theobturator shaft 3210. The septum seal 3242 prevents carbon dioxide fromleaking from the obturator 3200 when a laparoscope 3300 is insertedtherein. The duckbill valve 3244 prevents carbon dioxide from leaking inthe absence of a laparoscope 3300, for example, when the laparoscope3300 is withdrawn from the obturator 3200 or not used at all. Theillustrated embodiment also comprises a sleeve 3246 disposed proximallyof the septum seal 3242, which prevents and/or reduces inversion of theseptum seal 3242 on withdrawal of the laparoscope 3300 therefrom. Theseptum seal 3242 and the duckbill valve 3444 are disposed between theobturator shaft 3210 and the obturator handle 3230 in the illustratedembodiment. The obturator handle 3230 comprises a funneled entry 3232 atits proximal end leading into a guide channel 3234, which guides ordirects the laparoscope 3300 into the obturator 3200. Some embodimentsof the obturator handle 3230 comprise a space in the guide channel 3234sufficient to permit at least some septum seal 3234 inversion duringlaparoscope 3300 withdrawal without binding the laparoscope 3300. Forexample, in some embodiments, the diameter of the cap guide channel 3234is larger than the diameter of the laparoscope plus the thickness of theinverted septum seal, which is sufficient to prevent binding or lock-upof the laparoscope 3300 during withdrawal from the obturator 3200.

In some embodiments, at least one of the septum seal 3242 and duckbillvalve 3244 is treated by a chlorination process, which reduces frictionwhen inserting, rotating, and/or withdrawing the laparoscope 3300, whichtypically has a polished surface that generates high friction withseptum seals 3242 and duckbill valves 3244. In some embodiments, atleast one of the septum seal 3242 and duckbill valve 3244 is coated ortreated with one or more other anti-friction materials and/or coatings,such as silicone oil, silicone emulsion, parylene,polytetrafluoroethylene (Teflon®), and/or treated by plasma etching.

An embodiment of a method for using the surgical access or trocar systemrefers to the embodiment 1000 illustrated in FIGS. 1A-1E, although themethod is applicable to any of the embodiments discussed herein. In themethod, the bladeless obturator 1200 is first inserted through thetrocar seal 1120 and cannula 1110 of the trocar. A laparoscope 1300 isthen inserted into the proximal end of the bladeless obturator 1200 andadvanced to the stop 1224 or tip 1220 of the obturator. An endoscopicvideo camera (not illustrated) is attached to the proximal end of thelaparoscope 1300 and the access system 1000 is then axially advanced bya surgeon through a body wall. As the surgeon advances the access system1000 through the body wall, the surgeon visualizes the tissue as it isbeing separated, for example, using a video monitor connected to theendoscopic video camera. The surgeon can also readily determine when thebody wall has been traversed by observing the distal end of theobturator 1200 entering the body cavity. As discussed above, the distalend of the obturator 1200 includes insufflation vent holes 1222 throughwhich an insufflation gas may flow from the obturator 1200 and into abody cavity.

In another embodiment, the optical access system 1000 accesses atargeted body area or region under laparoscopic guidance as discussedabove, then is used to administer a medicament under vision. In someembodiments, the medicament is delivered through the stopcock 1124 andLuer fitting 1122, through the obturator 1200, and out through the ventholes 1222 disposed at the tip 1220 of the obturator. The term “venthole” is used here for consistency. Those skilled in the art willunderstand that in some embodiments, gas need not be delivered throughthe vent holes. Instead, the vent holes are used for another purpose,for example, for delivering a fluid, aspirating a fluid, withdrawingtissue, and/or as a gauge for placing the device, as discussed above.The trocar 1100, in this embodiment, is rigid, semi-rigid, or flexible.Some embodiments of the obturator 1200 comprise a single vent hole 1222.In some embodiments, the vent hole 1222 is disposed at the distal end ofthe tip 1220, generally along the longitudinal axis of the obturator1200, which permits a more precise delivery of the medicament. Theaccess system 1000 is suitable, for example, for rapidly accessing atrauma site and for rapidly delivering a medicament through theobturator under vision to the trauma site. In some embodiments, theobturator 1200 is usable in this application either with or without atrocar 1100. In embodiments that do not include a trocar, the obturator1200 comprises a fluid inlet, for example, a Luer fitting, disposed ator near the proximal end of the obturator 1200, for example, at thehandle 1230. The fluid inlet is fluidly connected to the vent hole 1222through the lumen of the obturator shaft 1210. These embodiments of thetrocar system 1100 are also useful for accessing a targeted body areaunder vision using an inserted laparoscope, then withdrawing a bodyfluid sample and/or a soft tissue sample through the vent or aspirationhole 1222 of the obturator, for example, for pathology analysis, withouta cannula.

In some embodiments, the access system 1000 further comprises aninsufflator comprising a gas flow alarm (not illustrated). In someembodiments, a source of insufflation gas, for example, an insufflator,is connected to the Luer fitting 1122, the stopcock valve 1124 opened,and the insufflation gas flow activated, for example, a carbon dioxideflow. When the tip 1220 of the obturator is placed in tissue such as theabdominal wall, the gas flow is blocked by the tissue, which in turnactivates a gas flow obstruction alarm of the insufflator. The gas flowobstruction alarm will continue as the trocar is advanced through thetissue until the vent holes 1222 in the tip of the obturator arepositioned within a hollow body cavity, at which point, carbon dioxideautomatically starts flowing into the cavity and the gas flowobstruction alarm on the insufflator deactivates, thereby serving as anaudible indicator that the distal tip 1222 of the obturator is properlypositioned within the body cavity.

Some embodiments of the access system 1000 further comprise an integralaudible indicator (not illustrated), which indicates gas flow, forexample, carbon dioxide, through the device. The audible indicatorproduces a sound, for example, a high-pitched tone, for example, bymechanically modulating the gas flow through the device. In someembodiments, the audible indicator is disposed in the trocar 1100. Insome embodiments in which the audible indicator is integral to thetrocar seal 1120, the audible indicator is positioned within and/orintegrated with the stopcock Luer fitting 1122. In other embodiments,the audible indicator is disposed in the obturator 1200. In yet otherembodiments, the audible indicator is a detachable component, forexample, disposed between and fluidly connecting the stopcock Luerfitting 1122 and the insufflation tubing.

In some embodiments, the access system 1000 comprising the audibleindicator is connected to an insufflator and the carbon dioxide gas flowactivated. When the tip 1220 of the obturator is placed in tissue, suchas the abdominal wall, the tissue blocks gas flow through the device. Asthe tip 1220 is advanced though the tissue, the gas flow remains blockeduntil the vent holes 1222 in the tip of the obturator reach the targetedbody cavity. When the vent holes 1222 are positioned within the bodycavity, the carbon dioxide automatically starts flowing into the cavity.The gas flow activates the audible indicator, thereby creating ahigh-pitched tone, which signals that the distal tip 1220 of theobturator is properly positioned within the body cavity.

Some embodiments of the access system 1000 further comprise a visualindicator (not illustrated), for example, a flow sight that indicatescarbon dioxide flow through the device. Suitable visual indicatorsinclude a flapper, a rotor, and/or an oscillating ball. In someembodiments, the visual indicator is integral to the trocar seal 1120,for example, positioned within and/or integrated with the stopcock Luerfitting 1122. In other embodiments, the visual indicator is disposedwithin the proximal portion of the obturator 1200. In other embodiments,the visual indicator is a detachable component disposed between the Luerfitting 1122 and the insufflation tubing.

In an embodiment of a method for using the trocar system comprising theintegral visual indicator, the trocar system is connected to aninsufflator and the carbon dioxide gas flow activated. When the tip 1220of the obturator is placed in tissue, such as the abdominal wall, thegas flow is blocked. As the tip 1220 is advanced though tissue, the gasflow remains blocked until the vent holes 1222 in the tip of theobturator enter the targeted body cavity. When the vent holes 1222 arepositioned within the body cavity, the carbon dioxide automaticallyflows into the body cavity. The gas flow causes movement of the visualflow indicator, thereby indicating that the distal tip of the obturatoris properly positioned within the body cavity.

Some embodiments of the access system 1000 comprise an electronic gasflow indicator. An output of the gas flow indicator is, for example,audible and/or visible.

While certain embodiments have been particularly shown and describedwith reference to exemplary embodiments thereof, it will be understoodby those of ordinary skill in the art that various changes in form anddetails may be made therein without departing from the spirit and scopethereof as defined by the following claims.

We claim:
 1. A surgical access system comprising: a tubular trocarcomprising a longitudinal axis, a proximal end, a distal end, anelongate cannula, and a seal assembly disposed at a proximal end of thecannula; a fluid inlet disposed at a proximal end of the access system;an obturator slidably insertable into the proximal end of the cannulaand through the seal assembly, the obturator comprising a longitudinalaxis, a proximal end, a distal end, a tubular shaft, a tapered tipdisposed at the distal end of the shaft, at least one vent hole disposedon the tip in fluid communication with the fluid inlet, and a handledisposed at the proximal end of the shaft; the obturator having an innersurface that defines an inner contour and an outer surface that definesan outer contour; the obturator having a wall thickness defined betweenthe inner surface and the outer surface; wherein, in transversecross-section of the tip, the outer contour has a generally rectangulartransverse cross-section which substantially matches the inner contourwhich also has a generally rectangular transverse cross-section; andwherein the wall thickness at the tip of the obturator is substantiallyuniform to reduce distortion of an image observed through the obturatortip.
 2. The surgical access system of claim 1 wherein the generallyrectangular cross-section has two oppositely disposed sides having alonger dimension interconnected by two oppositely disposed sides havinga relatively shorter dimension; wherein the shorter dimension of thegenerally rectangular inner surface of the tip of the obturator definesa stop for a laparoscope having a circular cross-section inserted intothe obturator.
 3. The surgical access system of claim 1 wherein thegenerally rectangular cross-section has two oppositely disposed sideshaving a longer dimension interconnected by two oppositely disposedsides having a relatively shorter dimension; wherein the obturator isconfigured such that a gas flow channel is defined between the longerdimension of the rectangular inner surface of the tip and the outersurface of a laparoscope inserted into the obturator.
 4. The surgicalaccess system of claim 1 wherein the cross-sectional area of theobturator tip increases in progressively proximal cross-sections of thetip.
 5. A surgical access system comprising: a tubular trocar comprisinga longitudinal axis, a proximal end, a distal end, an elongate cannula,and a seal assembly disposed at a proximal end of the cannula; a fluidinlet disposed at a proximal end of the access system; an obturatorslidably insertable into the proximal end of the cannula and through theseal assembly, the obturator comprising a longitudinal axis, a proximalend, a distal end, a tubular shaft, a tapered tip disposed at the distalend of the shaft, at least one vent hole disposed on the tip in fluidcommunication with the fluid inlet, and a handle disposed at theproximal end of the shaft; the obturator having an inner surface thatdefines an inner contour and an outer surface that defines an outercontour; the obturator having a wall thickness defined between the innersurface and the outer surface; a laparoscope having a longitudinal axis,a distal end, and a transverse cross section at the distal end that iscircular in shape; the distal end of the laparoscope is configured tocontact the inner surface of the tip defining a gas flow channel betweenthe laparoscope and the inner contour of the tip; wherein, in transversecross-section of the tip, the outer contour has a generally rectangulartransverse cross-section which substantially matches the inner contourwhich also has a generally rectangular transverse cross-section.